Gender differences in percutaneous coronary intervention for chronic total occlusions from the ERCTO study.

BACKGROUND: Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies. AIMS: We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI. METHODS: Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes. RESULTS: Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p < 0.001) and vascular complications (1.0% vs. 0.6%, p < 0.001). CONCLUSIONS: Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.

Predictors of target lesion failure after treatment of left main, bifurcation, or chronic total occlusion lesions with ultrathin-strut drug-eluting coronary stents in the ULTRA registry.

BACKGROUND: Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant. METHODS: The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis. RESULTS: Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%] from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95% CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95% CI: 0.12-0.82). CONCLUSIONS: Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome.

Management and outcomes of coronary artery perforations treated with the block and deliver technique.

OBJECTIVES AND BACKGROUND: Coronary artery perforation (CAP) is a potentially life-threatening complication during percutaneous coronary interventions (PCI) and the best strategy for its management is yet to be proved. We aimed to analyze the safety, efficacy, and long-term clinical outcomes of the block and deliver (BAD) technique, as only anecdotal cases are reported in literature. METHODS: From January 2016 to January 2020, all consecutive patients treated with the BAD technique at five high-volume centers in Italy were retrospectively identified. RESULTS: 25 CAPs treated with the BAD technique were included. The most frequently perforated artery was the left anterior descending artery (32%) and spring-coil wires with a hydrophilic coating were the most common culprit wires (68%). Mean sealing time was 46.9 ± 60.1 min, with no significant differences between CTO-PCIs and non-CTO PCIs (p = .921). Acute successful sealing of the CAP was achieved in 96% of the cases. Immediate cardiac tamponade occurred in 28% of patients, four during CTO PCI and three during non-CTO PCI (p = .55). Two patients required pericardiocentesis during hospitalization, one patient developed acute kidney injury, and one patient underwent cardiac surgery due to severe mitral regurgitation. At 1-year follow-up no significant differences were observed between groups in terms of POCE (25 vs 25%, p = .628) and its individual components. CONCLUSION: The BAD technique proved to be effective for the management of CAP, showing high successful sealing rates. Rates of in-hospital events and at 1-year follow-up did not significantly differ between patients suffering CAP during CTO revascularization or during non-CTO PCI.

Guiding Principles for Chronic Total Occlusion Percutaneous Coronary Intervention.

Outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have improved because of advancements in equipment and techniques. With global collaboration and knowledge sharing, we have identified 7 common principles that are widely accepted as best practices for CTO-PCI. 1. Ischemic symptom improvement is the primary indication for CTO-PCI. 2. Dual coronary angiography and in-depth and structured review of the angiogram (and, if available, coronary computed tomography angiography) are key for planning and safely performing CTO-PCI. 3. Use of a microcatheter is essential for optimal guidewire manipulation and exchanges. 4. Antegrade wiring, antegrade dissection and reentry, and the retrograde approach are all complementary and necessary crossing strategies. Antegrade wiring is the most common initial technique, whereas retrograde and antegrade dissection and reentry are often required for more complex CTOs. 5. If the initially selected crossing strategy fails, efficient change to an alternative crossing technique increases the likelihood of eventual PCI success, shortens procedure time, and lowers radiation and contrast use. 6. Specific CTO-PCI expertise and volume and the availability of specialized equipment will increase the likelihood of crossing success and facilitate prevention and management of complications, such as perforation. 7. Meticulous attention to lesion preparation and stenting technique, often requiring intracoronary imaging, is required to ensure optimum stent expansion and minimize the risk of short- and long-term adverse events. These principles have been widely adopted by experienced CTO-PCI operators and centers currently achieving high success and acceptable complication rates. Outcomes are less optimal at less experienced centers, highlighting the need for broader adoption of the aforementioned 7 guiding principles along with the development of additional simple and safe CTO crossing and revascularization strategies through ongoing research, education, and training.

Effectiveness of the "new rope coil" composite core Suoh 0.3 guidewire in the management of coronary artery dissections.

Coronary artery dissection is a well-known complication of percutaneous coronary interventions. In this setting, coronary artery dissection is caused by mechanical injury of the arterial wall. However, dissection may also occur spontaneously. In both situations, an intimal tear or dissection allows blood entering and separating the layers of the coronary arterial wall. Despite percutaneous approach is still the preferred and the quickest way to restore coronary flow, it remains challenging. One of the main reasons for procedural failure is due to the difficult advancement of a guidewire into the true lumen. In such situation, the ideal wire should have a soft tip, high torque control, and excellent flexibility. Assuming that, the "new rope coil" composite core Suoh 0.3 guidewire, with its unique combination of characteristics, could allow better orientation insight into a dissected coronary artery increasing the chance of procedural success. We collected a case series of nine consecutive patients in which the Suoh 0.3 guidewire was able to gain the true lumen distally to a dissected segment.

Outcomes with retrograde versus antegrade chronic total occlusion revascularization.

OBJECTIVES: The aim of the study was to evaluate the outcomes of retrograde versus antegrade approach in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The retrograde approach has increased the success rate of CTO PCI but has been associated with a higher risk for complications. METHODS: We conducted a meta-analysis of studies published between 2000 and August 2019 comparing the in-hospital and long-term outcomes with retrograde versus antegrade CTO PCI. RESULTS: Twelve observational studies (10,240 patients) met our inclusion criteria (retrograde approach 2,789 patients, antegrade approach 7,451 patients). Lesions treated with the retrograde approach had higher J-CTO score (2.8 vs. 1.9, p < .001). Retrograde CTO PCI was associated with a lower success rate (80.9% vs. 87.4%, p < .001). Both approaches had similar in-hospital mortality, urgent revascularization, and cerebrovascular events. Retrograde CTO PCI was associated with higher risk of in-hospital myocardial infarction (MI; odds ratio [OR] 2.37, 95% confidence intervals [CI] 1.7, 3.32, p < .001), urgent pericardiocentesis (OR 2.53, 95% CI 1.41-4.51, p = .002), and contrast-induced nephropathy (OR 2.12, 95% CI 1.47-3.08; p < .001). During a mean follow-up of 48 ± 31 months retrograde crossing had similar mortality (OR 1.79, 95% CI 0.84-3.81, p = .13), but a higher incidence of MI (OR 2.07, 95% CI 1.1-3.88, p = .02), target vessel revascularization (OR 1.92, 95% CI 1.49-2.46, p < .001), and target lesion revascularization (OR 2.08, 95% CI 1.33-3.28, p = .001). CONCLUSIONS: Compared with antegrade CTO PCI, retrograde CTO PCI is performed in more complex lesions and is associated with a higher risk for acute and long-term adverse events.

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes.

BACKGROUND: Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS: We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS: The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). CONCLUSIONS: In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).

Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial.

BACKGROUND: It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. METHODS: We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. FINDINGS: We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). INTERPRETATION: In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. FUNDING: The Medicines Company and Terumo.

Feasibility of carotid artery stenting with double cerebral embolic protection in high-risk patients.

BACKGROUND: Previous trials comparing carotid artery stenting (CAS) with carotid endarterectomy have shown that the former can increase the stroke rate. However, in the last years, because of the improvements either of the technique or the improvement of the stents and embolic protection devices (EPD), CAS has become a very competitive procedure. In this study, we tried to assess the feasibility and the safety of using double EPD (proximal and distal) in high-risk patients. METHODS: We collected data about all consecutive patients with carotid artery stenosis who underwent CAS and compared clinical and procedural characteristics as well as immediate and 30-day outcomes between the use of double vs. single EPD. RESULTS: Between November 2007 and August 2014, 294 patients underwent CAS. In 35 of them (11.9%) double EPD was used. In comparison with the patients treated with single EPD, those with double EPD presented more with acute carotid syndrome (recurrent TIAs < 48 hr, minor stroke < 14 days) and with complex plaque (79.4 vs. 33.6%, P < 0.0001). There was no difference between the 2 groups in primary success (100 vs. 99.6%, P = 0.16) and in 30-days major complications: death (0 vs. 0.8%, P = 0.6), major stroke (0 vs. 0.8%, P = 0.42), and minor stroke (0 vs 1.1%, P = 0.66). CONCLUSIONS: In our experience, in high-risk patients with high-risk lesions, the use of double EPD (proximal and distal) is safe and effective in minimizing the risk of cerebral embolization, but, to validate such a technique in wide range of patients, further studies are warranted.

Management strategies in patients affected by chronic total occlusions: results from the Italian Registry of Chronic Total Occlusions.

BACKGROUND: Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate. OBJECTIVES: The aim of the Italian Registry of Chronic Total Occlusions (IRCTO) was to provide data on prevalence, characteristics, and outcome of CTO patients according to the management strategy. METHODS: The IRCTO is a prospective real world multicentre registry enrolling patients showing at least one CTO. Clinical and angiographic data were collected independently from the therapeutic strategy [optimal medical therapy (MT), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)]; a comparative 1-year clinical follow-up was performed. RESULTS: A total of 1777 patients were enrolled for an overall CTO prevalence of 13.3%. The adopted therapeutic strategies were as follows: MT in 826 patients (46.5%), PCI in 776 patients (43.7%), and CABG in the remaining 175 patients (9.8%). At 1-year follow-up, patients undergoing PCI showed lower rate of major adverse cardiac and cerebrovascular events (MACCE) (2.6% vs. 8.2% and vs. 6.9%; P < 0.001 and P < 0.01) and cardiac death (1.4% vs. 4.7% and vs. 6.3%; P < 0.001 and P < 0.001) in comparison with those treated with MT and CABG, respectively. After propensity score-matching analysis, patients treated with PCI showed lower incidence of cardiac death (1.5 vs. 4.4%; P < 0.001), acute myocardial infarction (1.1 vs. 2.9%; P = 0.03), and re-hospitalization (2.3 vs. 4.4% P = 0.04) in comparison with those managed by MT. CONCLUSIONS: Our data showed how CTO PCI might significantly improve the survival and decrease MACCE occurrence at 1 year follow-up in comparison with MT and/or CABG.

Acute kidney injury after percutaneous coronary intervention: Rationale of the AKI-MATRIX (acute kidney injury-minimizing adverse hemorrhagic events by TRansradial access site and systemic implementation of angioX) sub-study.

Acute kidney injury (AKI) is an important complication of both diagnostic cardiac catheterization and percutaneous coronary intervention (PCI). A large body of evidence supports that AKI is related to volume of contrast used. Despite several measures are available to reduce the impact of contrast media on AKI, its incidence remains significant as other mechanisms of renal damage are involved. A new paradigm is established according to which bleeding prevention is at least as important as preventing recurrent ischemic events in the management of patients with acute coronary syndromes (ACS) undergoing an invasive approach. Periprocedural bleeding, which is consistently reduced by radial approach, is emerging as a risk factor for the development of AKI. Therefore, the role of vascular access as a measure to prevent AKI needs to be systematically assessed in randomized studies. To date, no prospective comparison on renal outcomes has been carried out in randomized trials between radial and femoral approach. The Minimizing Adverse hemorrhagic events by TRansradial access site and systemic Implementation of AngioX (MATRIX) trial (ClinicalTrials.gov identifier: NCT01433627) has been designed to test whether to minimize bleeding events by using radial access and bivalirudin, across the whole spectrum of patients with ACS undergoing PCI, will result in improved outcomes with respect to both ischemic and bleeding complications. The AKI-MATRIX sub-study will provide a unique opportunity to assess whether the advantages of radial approach may even contribute to the reduction of the risk of AKI in patients with ACS.

Effect of Abciximab Therapy in Patients Undergoing Coronary Angioplasty for Acute ST-Elevation Myocardial Infarction Complicated by Cardiogenic Shock.

BACKGROUND: The effect of abciximab on survival in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) undergoing primary percutaneous coronary intervention (PCI) is not clear. METHODS AND RESULTS: We evaluated outcome in 410 consecutive patients with STEMI and CS who underwent PCI treated without (n=123) or with (n=287) abciximab. The endpoint was survival at 1-year follow-up. The predictors of death at 1 year were also investigated. The groups with and without abciximab had similar survival at 1-year follow-up. Propensity score-adjusted Cox proportional hazards model identified age (adjusted hazard ratio [HR], 1.02; 95% confidence interval [95% CI]: 1.01-1.03, P=0.001), oro-tracheal intubation (HR, 1.49; 95% CI: 1.12-1.96, P=0.05), post-PCI TIMI flow grade 0-1 (HR, 2.08; 95% CI: 1.52-2.83, P=0.0001) but not abciximab use (HR, 1.08; 95% CI: 0.70-1.60, P=0.60) as independent predictors of death at 1-year follow-up. Cox adjusted 1-year survival rates were 42.8% and 51.6%, (P=0.56) in patients treated without vs. with abciximab, respectively. CONCLUSIONS: Patients with STEMI complicated by CS undergoing PCI treated with or without abciximab have similar 1-year survival rates; age, final TIMI 0-1 and oro-tracheal intubation are predictors of death.

Update on chronic total occlusion percutaneous coronary intervention.

Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) continues to evolve. This review summarizes recent publications categorized by outcomes, techniques, complications, and ongoing studies in this rapidly growing area.

Clinical outcomes following percutaneous coronary intervention with drug-eluting stents versus bare metal stents in patients on chronic hemodialysis.

BACKGROUND: Patients on chronic hemodialysis (HD) are recognized as a high-risk group for adverse events after percutaneous coronary intervention, and whether drug-eluting stents (DES) are associated with improved outcomes over bare metal stents (BMS) is still uncertain. The purpose of this study was to assess the efficacy of DES compared with BMS at short- and long-term follow-up (FU) in an unselected sample of HD patients. METHODS AND RESULTS: In the time period 2005-2010, consecutive patients on chronic HD treated with percutaneous coronary intervention (PCI) and stent implantation were retrospectively selected and analyzed. A total of 169 patients were selected, 77 treated exclusively with BMS and 92 exclusively with DES. Baseline clinical characteristics were similar in the 2 groups as well as the number of treated vessels, treated lesions, and the stent per patient ratio. At longest available FU, no difference between the 2 study groups was found in terms of cardiac death (18.2% vs 16.3%, P=0.83), myocardial infarction (2.5% vs 8.6%, P=0.09), cerebrovascular accidents (0% vs 1.1%, P=0.98), and target vessel revascularization (TVR) (9.1% vs 16.3%, P=0.17). Major adverse cardiac and cerebrovascular events-free survival at 1,500 days in the BMS and DES groups was 57.6% and 50.9% (P=0.11), respectively. CONCLUSIONS: PCI in patients on chronic HD treatment is associated with a high incidence of adverse events at FU, mainly represented by death. In our study, the use of DES was not associated with a reduction of target lesion revascularization (TLR) and TVR.

Utility of Guiding Catheter Extensions for Recanalization of Chronic Total Occlusions: A EuroCTO Club Expert Panel Report.

Guiding catheter extensions (GCEs) have become indispensable tools in the modern approach to percutaneous coronary intervention (PCI). The support offered during complex PCI of uncrossable, or tortuous lesions is particularly valuable in the setting of chronic total occlusions (CTO), both for conventional anterograde wire escalation and for anterograde or retrograde dissection and re-entry techniques. This EuroCTO consensus document describes the use of GCE during CTO recanalization and provides a practical guide to anatomies and techniques in which these devices are applicable. We describe the peculiar features of the most-used device and the practical technique for GCE delivery in standard PCI; further specific indications for antegrade and retrograde CTO PCI are discussed in a specific section. In the antegrade approach, the GCEs may be useful to increase support or facilitate antegrade dissection and re-entry techniques, while in the retrograde approach for reverse controlled antegrade and retrograde tracking, to increase retrograde support for gear delivery, for treatment of CTO in bifurcation and ipsilateral externalization with a single guide catheter. The last section of the paper describes GCE-related complications, challenges, limitations, and future perspectives.

Validation of a Contemporary Acute Kidney Injury Risk Score in Patients With Acute Coronary Syndrome.

BACKGROUND: A simple, contemporary risk score for the prediction of contrast-associated acute kidney injury (CA-AKI) after percutaneous coronary intervention (PCI) was recently updated, although its external validation is lacking. OBJECTIVES: The aim of this study was to validate the updated CA-AKI risk score in a large cohort of acute coronary syndrome patients from the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of angioX) trial. METHODS: The risk score identifies 4 risk categories for CA-AKI. The primary endpoint was to appraise the receiver-operating characteristics of an 8-component and a 12-component CA-AKI model. Independent predictors of Kidney Disease Improving Global Outcomes-based acute kidney injury and the impact of CA-AKI on 1-year mortality and bleeding were also investigated. RESULTS: The MATRIX trial included 8,201 patients with complete creatinine values and no end-stage renal disease. CA-AKI occurred in 5.5% of the patients, with a stepwise increase of CA-AKI rates from the lowest to the highest of the 4 risk categories. The receiver-operating characteristic area under the curve was 0.67 (95% CI: 0.64-0.70) with model 1 and 0.71 (95% CI: 0.68-0.74) with model 2. CA-AKI risk was systematically overestimated with both models (Hosmer-Lemeshow goodness-of-fit test: P < 0.05). The 1-year risks of all-cause mortality and bleeding were higher in CA-AKI patients (HR: 7.03 [95% CI: 5.47-9.05] and HR: 3.20 [95% CI: 2.56-3.99]; respectively). There was a gradual risk increase for mortality and bleeding as a function of the CA-AKI risk category for both models. CONCLUSIONS: The updated CA-AKI risk score identifies patients at incremental risks of acute kidney injury, bleeding, and mortality. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627).

Coronary calcification in patients presenting with acute coronary syndromes: insights from the MATRIX trial.

AIMS: The role of coronary calcification on clinical outcomes among different revascularization strategies in patients presenting with acute coronary syndromes (ACSs) has been rarely investigated. The aim of this investigation is to evaluate the role of coronary calcification, detected by coronary angiography, in the whole spectrum of patients presenting with acute ACS. METHODS AND RESULTS: The present study was a post hoc analysis of the MATRIX programme. The primary endpoint was major adverse cardiovascular events (MACE), defined as the composite of all-cause mortality, myocardial infarction (MI), or stroke up to 365 days. Among the 8404 patients randomized in the MATRIX trial, data about coronary calcification were available in 7446 (88.6%) and therefore were included in this post hoc analysis. Overall, 875 patients (11.7%) presented with severe coronary calcification, while 6571 patients (88.3%) did not present severe coronary calcification on coronary angiography. Fewer patients with severe coronary calcification underwent percutaneous coronary intervention whereas coronary artery bypass grafting or medical therapy-only was more frequent compared with patients without severe calcification. At 1-year follow-up, MACE occurred in 237 (27.1%) patients with severe calcified coronary lesions and 985 (15%) patients without severe coronary calcified lesions [hazard ratio (HR) 1.91; 95% confidence interval (CI) 1.66-2.20, P < 0.001]. All-cause mortality was 8.6% in patients presenting with and 3.7% in those without severe coronary calcification (HR 2.38, 1.84-3.09, P < 0.001). Patients with severe coronary calcification incurred higher rate of MI (20.1% vs. 11.5%, HR 1.81; 95% CI 1.53-2.1, P < 0.001) and similar rate of stroke (0.8% vs. 0.6%, HR 1.35; 95% CI 0.61-3.02, P = 0.46). CONCLUSION: Patients with ACS and severe coronary calcification, as compared to those without, are associated with worse clinical outcomes irrespective of the management strategy.

Percutaneous left main coronary disease treatment without on-site surgery back-up in patients with acute coronary syndromes: immediate and 2-year outcomes.

BACKGROUND: Best revascularization strategy in patients with acute coronary syndromes (ACS) and unprotected left main (ULM) coronary disease is still debate reflecting lack of convincing data. OBJECTIVES: To assess clinical feasibility and efficacy of ULM percutaneous coronary intervention (PCI) in patients with ACS and describe the practice of a center without on-site surgical back-up over a 7-year period. METHODS: Data on high-risk patients with ACSs undergoing percutaneous ULM treatment were prospectively collected in an independent registry. Primary end-points of this study were immediate and long-term outcomes expressed as target lesion failure (TLF, composite of cardiac death, myocardial infarction (MI), and target lesion revascularization). RESULTS: Between January 2003 and January 2010, 200 consecutive patients were included in this study. Angiographic success was obtained in 95% of patients but procedural success was 87% primarily affected by an 11% of in-hospital cardiac mortality. At median follow-up of 26 months (IQ 10-47), the overall TLF rate was 28.5%, with 16.0% of cardiac death, 7.0% of MI, and 10.5% of clinically driven target lesion revascularization rates. Cumulative definite/probable stent thrombosis was 3.5%. Elevated EuroSCORE value and pre-procedural hemodynamic instability were the strongest predictors of TLF. Temporal trend analysis showed progressive but not significant improvement for both immediate (P = 0.110) and long-term (P = 0.073) outcomes over the study period. CONCLUSIONS: This single-center study based on current clinical practice in patient with ULM disease and ACS confirmed PCI as feasible revascularization strategy in absence of on-site cardio-thoracic support. Nevertheless, the outcome of these high-risk patients is still hampered by a sensible in-hospital mortality rate.

A Systematic Review and Meta-Analysis of Clinical Outcomes of Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention.

OBJECTIVES: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can improve patient symptoms, but it remains controversial whether it impacts subsequent clinical outcomes. METHODS: In this systematic review and meta-analysis, we queried PubMed, ScienceDirect, Cochrane Library, Web of Science, and Embase databases (last search: September 15, 2021). We investigated the impact of CTO-PCI on clinical events including all-cause mortality, cardiovascular death, myocardial infarction (MI), major adverse cardiovascular event (MACE), stroke, subsequent coronary artery bypass surgery, target-vessel revascularization, and heart failure hospitalizations. Pooled analysis was performed using a random-effects model. RESULTS: A total of 58 publications with 54,540 patients were included in this analysis, of which 33 were observational studies of successful vs failed CTO-PCI, 19 were observational studies of CTO-PCI vs no CTO-PCI, and 6 were randomized controlled trials (RCTs). In observational studies, but not RCTs, CTO-PCI was associated with better clinical outcomes. Odds ratios (ORs) and 95% confidence intervals (CIs) for all-cause mortality, MACE, and MI were 0.52 (95% CI, 0.42-0.64), 0.46 (95% CI, 0.37-0.58), 0.66 (95% CI, 0.50-0.86), respectively for successful vs failed CTO-PCI studies; 0.38 (95% CI, 0.31-0.45), 0.57 (95% CI, 0.42-0.78), 0.65 (95% CI, 0.42-0.99), respectively, for observational studies of CTO-PCI vs no CTO-PCI; 0.72 (95% CI, 0.39-1.32), 0.69 (95% CI, 0.38-1.25), and 1.04 (95% CI, 0.46-2.37), respectively for RCTs. CONCLUSIONS: CTO-PCI is associated with better subsequent clinical outcomes in observational studies but not in RCTs. Appropriately powered RCTs are needed to conclusively determine the impact of CTO-PCI on clinical outcomes.